Mr. Nicholas Kadysh reports

PHARMALA SIGNS DRUG DONATION AGREEMENT FOR MDMA-ASSISTED THERAPY CLINICAL TRIAL IN FIBROMYALGIA

Pharmala Biotech Holdings Inc. has executed an agreement with Spaulding Rehabilitation, a member of the Mass General Brigham health care system, for the provision of MDMA for use in a clinical trial investigating MDMA-assisted (3,4-methylenedioxymethamphetamine) therapy for the treatment of fibromyalgia.

Under the agreement, Pharmala will provide its LaNeo MDMA at no charge to Spaulding Rehabilitation for use in a study entitled "Hyperscan Neuroimaging to Reveal the Brain Mechanisms Supporting Analgesia Following MDMA-Assisted Therapy in Fibromyalgia" in exchange for a licence to the study results. The study will be conducted under the direction of principal investigator Dr. Vitaly Napadow, PhD, of Spaulding Rehabilitation in Boston, Mass.

Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue and cognitive difficulties, affecting an estimated four million adults in the United States alone. The study will employ advanced hyperscan neuroimaging techniques to investigate the brain mechanisms underlying pain relief following MDMA-assisted therapy, representing a novel application of MDMA beyond its more widely studied use in the treatment of posttraumatic stress disorder (PTSD).

Investigator perspectives

"Fibromyalgia is a condition in which subjective pain, brain circuitry and interpersonal context are tightly intertwined," said Dr. Napadow, principal investigator of the study and director of the Scott Schoen and Nancy Adams Discovery Center for Chronic Pain Recovery at Spaulding Rehabilitation. "By using hyperscan neuroimaging, this study allows us to examine how MDMA-assisted therapy may influence not only individual brain activity, but co-ordinated brain-to-brain dynamics that are increasingly recognized as important for therapeutic alliance, pain modulation and analgesia. Our aim is to better understand the neural mechanisms that support meaningful pain relief, rather than focusing solely on symptom change."

"Fibromyalgia sits at a difficult crossroads between mind and body, where neither purely biomedical nor purely psychological models are sufficient," said Dr. Franklin King, MD, psychiatry lead co-investigator and director of training and education at the Center for the Neuroscience of Psychedelics at Massachusetts General Hospital. "MDMA-assisted therapy offers a unique opportunity to engage this interface by simultaneously influencing affective, cognitive and embodied aspects of pain. This study reflects a broader effort to explore integrated approaches for complex, treatment-resistant conditions that do not fit neatly into traditional clinical categories."

Expanding research collaborations

"This agreement marks an important expansion of the clinical research into LaNeo MDMA beyond PTSD and into new therapeutic indications," said Nicholas Kadysh, chief executive officer of Pharmala Biotech. "Fibromyalgia affects millions of patients worldwide, and current treatment options are limited. We are excited to support this groundbreaking research into the potential analgesic mechanisms of MDMA-assisted therapy, and we look forward to the important data that will emerge from this study."

As part of this collaboration, Spaulding will deliver comprehensive study results to Pharmala -- including group means, pretherapy and posttherapy analyses, and regression analysis plots -- within 90 days of the study's completion. Pharmala will have the ability to leverage these findings for a broad range of public applications, including potential regulatory submissions, while Spaulding retains the right of first publication in a peer-reviewed journal. Intellectual property arising from the study will be held by the respective parties best positioned to advance its potential, with Pharmala retaining rights to innovations directly related to the study drug and Spaulding retaining rights to discoveries made independently by its research team.

Researchers interested in accessing LaNeo MDMA for clinical trials may visit Pharmala's website for additional information, including access to drug product quality documentation.

About Pharmala Biotech Holdings Inc.

Pharmala Biotech is a biotechnology company focused on the research, development and manufacturing of MDXX-class molecules, including MDMA. Pharmala was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions and to develop novel drugs in the same class. Pharmala is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. Pharmala's research and development unit has completed proof-of-concept research into several IP (intellectual property) families, including ALA-002, its lead drug candidate. Pharmala is a regulatory-first organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.

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